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Experiences

  • Bédard est président de Crescentia, consultants en entreprise et vice-président de PBE Pharma Expert, société d’ingénierie et de conformité réglementaire pour les industries pharmaceutique, de la biotechnologie et du cannabis. Il a plus de 30 ans d’expérience en affaires.
  • Du 5 juillet 2015 au 12 mars 2017: M. Bédard était vice-président des opérations chez Mesa Canada et vice-président mondial des ventes chez Mesa Labs. Il faisait également partie du conseil d’administration de Mesa Labs (Nasdaq: MLAB).
  • De juin 2012 au 5 juillet 2015: M. Bédard a été président et chef de la direction d’Infitrak et chef de la direction de Circulo Pharma Systems Inc., dont les activités sont intégrées en deux axes. Le premier concerne les services de conformité réglementaire de la chaîne du froid pour le marché des sciences de la vie; services techniques; système de surveillance environnemental et solutions de gestion des enregistreurs de données; conception, test et qualification d’emballage spécialisé (Infitrak Inc.). La seconde est davantage axée sur la conformité des échantillons de médicaments et la gestion de la documentation marketing (Circulo Pharma Systems).
  • De 2004 à 2011: en tant que PDG, il a dirigé une équipe d’experts en chaîne du froid chez Alternatives Technology Pharma, dont les activités sont les suivantes: services de conformité réglementaire; services techniques; système de surveillance environnemental et solutions de gestion des enregistreurs de données.
  • Bédard a été vice-président de Validapro de 1997 à 2004 et a dirigé les bureaux de Montréal (Canada), Toulouse (France) et Genève (Suisse). Il a dirigé la conception, l’ingénierie, la mise en service et la validation d’installations de biotechnologie et pharmaceutiques dans plus de 22 pays.
  • Bédard a géré plus de 1 000 programmes de conformité aux BPF et au BPD au Canada, aux États-Unis et en Europe destinés aux grossistes / distributeurs, sociétés pharmaceutiques et biotechnologiques, transporteurs, 3PL, hôpitaux, banques de sang, sociétés de matériel médical, CRO et CMO.
  • Bédard est titulaire d’un MBA en gestion de la bio-industrie et fait partie de nombreuses associations et organisations liées à la science, à la chaîne du froid et à la traçabilité.

Expertise & Compétences

  • Gouvernance
    • Conseil d’administration de Mesa Labs (Nasdaq: MLAB)
    • Conseil d’administration Infitrak
    • Conseil d’administration Alternative Technology Pharma
    • Conseil d’administration de Circulo Pharma Systems
    • Comité stratégique Mesa Labs et Comité stratégique Inftrak.
  • Financement
    • Au cours de sa carrière, M. Bedard a reçu du financement sous différentes formes (subventions, prêt bancaire, anges et capital de risque) de 50 000,00 $ à 7 000 000,00 $.
  • Comptabilité
    • Bonne connaissance des bonnes pratiques comptables (États-Unis et Canada).
  • Opérations
    • A géré jusqu’à 540 employés répartis sur 6 sites en Amérique du Nord
    • A géré l’implémentation d’un ERP
    • A développé et géré le développement technologique de plusieurs projets importants
    • A géré les opérations de fabrication et de services / solutions de plusieurs entreprises.
  • Ventes et marketing
    • Gestion d’une équipe marketing de 6 ressources et d’une équipe de vente de 14 directeurs de comptes chez Mesa Labs
    • Gestion d’une équipe de vente de 7 directeurs de comptes chez Infitrak
    • Dans chaque entreprise qu’il possédait ou dirigeait, M. Bédard a toujours connu une croissance rapide.
    • Lorsqu’il a rejoint Infitrak en 2012, la société réalisait un chiffre d’affaires de 400 000 USD. 4 ans plus tard, la société avait atteint plus de 20 000 000,00 $ de ventes.
  • Fusion et acquisition
    • Au cours de son emploi chez Mesa Labs, M. Bédard a acheté 3 sociétés d’indicateurs biologiques, de la négociation, à la vérification diligente jusqu’à l’achat.
  • Vente d’entreprises
    • Bédard a vendu 2 entreprises; Alternatives Technologie Pharma et Infitrak.
    • La première a été vendu 2 500 000 USD à une entreprise américaine. Infitrak a été vendu à Mesa Labs pour 28 000 000 USD trois ans seulement après sa prise de contrôle.

Formations

  • Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and Quality Assurance
    • Introduction to GMPs
    • GMPs for Canada, the US and Europe: Differences and similarities
    • GMPs for Quality Control Laboratories
    • Good Distribution Practices
    • Standard Operating Procedures (SOP)
    • CFR21 part11 / CAPA / In-process controls
    • Manufacturing documentation
    • Quality Assurance and Quality Control
    • Management of deviations and non-conformances
    • Cold Chain Deviations, OOS, Change Control and CAPA
  • Validation
    • Validation Master Plan
    • Validation : General concepts / protocols
    • Validation : From theory to practice
    • Validation of manufacturing processes
    • Validation of sterilization processes
    • Validation of aseptic filtration processes
    • Validation of cleaning processes
    • Validation and Engineering
    • Validation of analytical methods
    • Validation of transportation processes
    • Qualification of thermal equipment
    • Qualification of trailers/trucks
    • Design and Qualification of packaging methods
    • Software validation
    • Temperature mapping study
    • Temperature profile study in transport
  • Engineering
    • Design of clean rooms
    • Major elements of purified water systems
    • Ventilation systems in the pharmaceutical industry
  • Audits
    • Preparation to a Pre-Approval Inspection(FDA)
    • Systems-based Inspections (FDA)
    • GDP and Cold Chain Gap analysis
    • Quality agreements
    • Internal and external audits
  • Medical devices
    • Good manufacturing practices (GMPs): QSR & ISO 13485

Ateliers & Conférences

  • Ateliers 
    • IQPC Philadelphia 2010: Performing an efficient Cold Chain Compliance and Process Gap Analysis.
    • IQPC Toronto 2011: Identifying temperature profiles to address the challenges of the Canadian market shipping lanes.
  • Conférences
    • Pharma Supply Chain, 2007:Developing temperature monitoring protocols to comply with Cold Chain standards and legislation while delivering safe products to the customer.
    • PPCLA 2007: Storage and distribution of drug products: ensuring optimal Cold Chain management through Mckesson Canada’s distribution network.
    • IQPC 2007, Toronto: Temperature profiling to determine trends and maintain temperature control
    • PPCLA, 2008, Toronto: Good Cold Chain practices, regulatory compliance and monitoring systems
    • IQPC 2008, Toronto: Good Cold Chain practices
    • PDA 2009, Bethesda: Relying on new technologies to meet temperature challenges during warehousing and transportation
    • International Pharmaceutical Academy 2009, Montreal: Good Practices in Cold Chain management through the Canadian distribution network
    • IQPC 2009, Toronto: Case study: Storage and distribution of drug products; ensuring optimal Cold Chain management through the Canadian distribution network.
    • IQPC 2010, Toronto: New monitoring technologies to meet temperature challenges during warehousing and transportation
    • The Pharmaceutical Supply Chain Summit, 2010, Baltimore:Automation & access: bringing the temperature regulation in your product’s supply chain to your fingertips
    • IQPC 2014, Montreal: Case study for Shoppers Drug Mart packaging system validation & Best Practices for a validated packaging system.
    • IQPC 2015, Montreal: Temperature profiles in Transport in North America
    • IQPC 2016, Boston: Life cycle of a packaging system
    • IQPC 2016, Toronto: Life cycle of a packaging system
    • IQPC 2017, Toronto: Protecting clinical trial shipments in transport.

Experiences

  • Bédard is President of Crescentia, business consultant and Vice President of PBE Pharma Expert Inc, process and regulatory compliance company for pharmaceutical, biotech and cannabis industry. He has over 30 years of experience in business.
  • From July 5th, 2015 to March 12, 2017, M. Bédard was Vice President Operations at Mesa Canada and Global Vice President, Sales at Mesa Labs.
  • He was also part of the board of director of Mesa Labs (Nasdaq: MLAB). From June 2012 to July 5th, 2015, M. Bédard was President and CEO of Infitrak and CEO of Circulo Pharma Systems Inc. which activities are integrated into two major axes.
  • The first one covers Cold Chain Regulatory Compliance Services for the Life Sciences market; Technical services; Environmental Monitoring and Data Logger Management Solutions; Design, Test and Qualification of Cold Chain Packaging and Services related to Cold Chain Management (Infitrak Inc.). The second is more focused on compliance of drug samples and marketing documentation management (Circulo Pharma Systems).
  • From 2004 to 2011, as CEO, he headed a team of Cold Chain Experts at Alternatives Technology Pharma, which activities are: Regulatory Compliance Services; Technical services (Thermal mapping and studies); Environmental Monitoring and Data Logger Management Solutions; Design, Test and Qualification of Cold Chain Packaging and Cold Chain Packaging Supplies.
  • Bédard was Vice-president of Validapro from 1997 to 2004 and managing the Montréal (Canada), Toulouse (France) and Geneva (Switzerland) offices and has managed the design, engineering, commissioning and validation of biotech and pharmaceutical facilities in more than 22 countries.
  • Bédard has managed more than 1 000 GMP and GDP Compliance programs in Canada, US and Europe for large Wholesalers/Distributors, Pharma and Biotech companies, Carriers/Transporters, 3PLs, Hospitals, Blood Banks, Medical Device companies, CROs and CMOs.
  • Bédard holds a MBA in Bio-industry Management and he is part of many associations and organisations related to science, cold chain and track & trace.

Expertise & skills

  • Governance
    • Board of directors Mesa Labs (Nasdaq: MLAB)
    • Board of directors Infitrak
    • Board of director Alternative Technology Pharma
    • Board of director Circulo Pharma Systems
    • Strategic committee Mesa Labs
    • Strategic committee Inftrak
  • Financing
    • During his business carreer, M. Bedard received financing in different forms (subsidies, bank loan, angel money and venture capital) from $50,000.00 to $7,000,000.00
  • Accounting
    • Good knowledge of good accounting practices (USA and Canada)
  • Operations
    • Managed up to 540 employees located in 6 locations in North America
    • Managed the implementation of an ERP
    • Managed technology development roadmaps
    • Managed the manufacturing and services/solutions operations of multiple companies
  • Sales and marketing
    • Managed a marketing team of 6 resources and a sales team of 14 account managers at Mesa Labs
    • Managed a sales team of 7 account managers at Infitrak
    • In every business that he owned or managed, M. Bédard always achieved fast growth
    • When he joined Infitrak in 2012, the company had sales of $400,000.00. 4 years later, the company was selling over $20,000,000.00 in sales
  • Merge and acquisition
    • During his employment at Mesa labs, M. Bédard bought 3 biological indicators companies, from negotiation, due diligence to purchase.
  • Selling
    • Bédard sold 2 companies; Alternative Technology Pharma and Infitrak. The first was sold for $2,500,000.00 to a US based company. Infitrak was sold to Mesa Labs for $28,000,000.00 after only 3 years after he took over the company.

Training

  • Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and Quality Assurance
    • Introduction to GMPs
    • GMPs for Canada, the US and Europe: Differences and similarities
    • GMPs for Quality Control Laboratories
    • Good Distribution Practices
    • Standard Operating Procedures (SOP)
    • CFR21 part11 / CAPA / In-process controls
    • Manufacturing documentation
    • Quality Assurance and Quality Control
    • Management of deviations and non-conformances
    • Cold Chain Deviations, OOS, Change Control and CAPA
  • Validation
    • Validation Master Plan
    • Validation : General concepts / Protocols
    • Validation : From theory to practice
    • Validation of manufacturing processes
    • Validation of sterilization processes
    • Validation of aseptic filtration processes
    • Validation of cleaning processes
    • Validation and Engineering
    • Validation of analytical methods
    • Validation of transportation processes
    • Qualification of thermal equipment
    • Qualification of trailers/trucks
    • Design and Qualification of packaging methods
    • Software validation
    • Temperature mapping study
    • Temperature profile study in transport
  • Engineering
    • Design of clean rooms
    • Major elements of purified water systems
    • Ventilation systems in the pharmaceutical industry
  • Audits
    • Preparation to a Pre-Approval Inspection(FDA)
    • Systems-based Inspections (FDA)
    • GDP and Cold Chain Gap analysis
    • Quality agreements
    • Internal and external audits
  • Medical devices
    • Good manufacturing practices (GMPs): QSR & ISO 13485

Workshops & Conferences

  • Workshops 
    • IQPC Philadelphia 2010: Performing an efficient Cold Chain Compliance and Process Gap Analysis.
    • IQPC Toronto 2011: Identifying temperature profiles to address the challenges of the Canadian market shipping lanes.
  • Conferences
    • Pharma Supply Chain, 2007:Developing temperature monitoring protocols to comply with Cold Chain standards and legislation while delivering safe products to the customer.
    • PPCLA 2007: Storage and distribution of drug products: ensuring optimal Cold Chain management through Mckesson Canada’s distribution network.
    • IQPC 2007, Toronto: Temperature profiling to determine trends and maintain temperature control
    • PPCLA, 2008, Toronto: Good Cold Chain practices, regulatory compliance and monitoring systems
    • IQPC 2008, Toronto: Good Cold Chain practices
    • PDA 2009, Bethesda: Relying on new technologies to meet temperature challenges during warehousing and transportation
    • International Pharmaceutical Academy 2009, Montreal: Good Practices in Cold Chain management through the Canadian distribution network
    • IQPC 2009, Toronto: Case study: Storage and distribution of drug products; ensuring optimal Cold Chain management through the Canadian distribution network.
    • IQPC 2010, Toronto: New monitoring technologies to meet temperature challenges during warehousing and transportation
    • The Pharmaceutical Supply Chain Summit, 2010, Baltimore:Automation & access: bringing the temperature regulation in your product’s supply chain to your fingertips
    • IQPC 2014, Montreal: Case study for Shoppers Drug Mart packaging system validation & Best Practices for a validated packaging system.
    • IQPC 2015, Montreal: Temperature profiles in Transport in North America
    • IQPC 2016, Boston: Life cycle of a packaging system
    • IQPC 2016, Toronto: Life cycle of a packaging system
    • IQPC 2017, Toronto: Protecting clinical trial shipments in transport.
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